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Chinese CKD-MBD Prevalence Survey (CRISS-MBD)

Recruiting
Conditions
Chronic Kidney Disease-Mineral and Bone Disorder
Chronic Kidney Diseases
Registration Number
NCT04714918
Lead Sponsor
Limeng Chen
Brief Summary

This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population.

Detailed Description

The prevalence of Chronic Kidney Disease (CKD) in Chinese population is over 10% and increasing rapidly. Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) is a constellation of conditions secondary to CKD, including 1) metabolic disorders of calcium, phosphorus and Parathyroid Hormone (PTH), 2) bone diseases and 3) calcifications in blood vessels and soft tissues. CKD-MBD could increase the risks of cardiovascular diseases and bone fracture and overall mortality. However, the data of prevalence of CKD-MBD in Chinese population with different CKD stages is lacking. This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population.This is a multi-center cross sectional epidemiological study. The purpose of this study is to investigate the prevalence of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) in Chinese population. A questionnaire was designed to collect the information of demographic data, medical history, laboratory test results and medications from the patients. Multistage stratified cluster sampling method will be used. Based on the sample size estimation, a total of 14-28 tertiary hospitals and 42-56 level II hospitals distributed in seven different geographic regions across China will be included. At least 9863 subjects will be enrolled. The primary outcome is the prevalence of CKD-MBD, including the prevalence of hypocalcemia, hyperphosphatemia and secondary hyperparathyroidism.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
10254
Inclusion Criteria
  • Kidney damage for β‰₯ 3 months, and one of the following criteria:

    1. Glomerular filtration rate (GFR) <60 mL/min/1.73m2 for 3 months or more, irrespective of cause.
    2. proteinuria (>30 mg of urinary albumin excretion per gram of urinary creatinine, > 50 mg of urinary protein excretion per gram of urinary creatinine, >1+ for proteinuria in dipstick, > 0.3g of 24 hour urine protein)
    3. structural renal abnormalities
  • hospitalized patients not on dialysis or dialysis patients followed regularly in Hemodialysis centers or Peritoneal Dialysis centers

Exclusion Criteria
  • no available test results within 3 months prior to this study
  • no available information of medication or past medical history

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The prevalence of hyperphosphatemiaAt the end of the enrollment.

The prevalence of hyperphosphatemia (serum phosphate \> 1.45mmol/L) in the whole study population and in participants with different CKD stages.

Secondary Outcome Measures
NameTimeMethod
The prevalence of hypocalcemiaAt the end of the enrollment.

The prevalence of hypocalcemia (serum calcium \< 2.13mmol/L) in the whole study population and in participants with different CKD stages.

The prevalence of secondary hyperparathyroidismAt the end of the enrollment.

The prevalence of secondary hyperparathyroidism (iPTH \> 300pg/ml) in the whole study population and in participants with different CKD stages.

The prevalence of bone fractureAt the end of the enrollment.

The prevalence of bone fracture in the whole study population and in participants with different CKD stages.

The prevalence of hypercalcemiaAt the end of the enrollment.

The prevalence of hypercalcemia (serum calcium \> 2.70mmol/L) in the whole study population and in participants with different CKD stages.

The prevalence of vascular calcificationAt the end of the enrollment.

The prevalence of vascular calcification identified by CT scan or ultrasound in the whole study population and in participants with different CKD stages.

Trial Locations

Locations (40)

The First Hospital of Fangshan District, Beijing

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Beijing, Beijing, China

Third People's Hospital of Yiyang

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Yiyang, Hunan, China

The Fifth People's Hospital of Ningxia Hui Autonomous Region

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Shizuishan, Ningxia, China

People's Hospital of Wuzhong

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Wuzhong, Ningxia, China

People's Hospital of Tongxin County

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Wuzhong, Ningxia, China

People's Hospital of Yanchi County

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Wuzhong, Ningxia, China

People's Hospital of Yuanzhou District

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Wuzhong, Ningxia, China

Ningxia Chinese Medicine Research Center

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Yinchuan, Ningxia, China

People's Hospital of Ningxia Hui Autonomous Region

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Yinchuan, Ningxia, China

People's Hospital of Xinjiang Uygur Autonomous Region

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Ürümqi, Xinjiang, China

The Second Affiliated Hospital Zhejiang University School of Medicine

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Hangzhou, Zhejiang, China

Beijing Tiantan Hospital, Capital Medical University

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Beijing, Beijing, China

Peking Union Medical College Hospital

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Beijing, Beijing, China

Beijing Lu-He Hospital, Capital Medical University

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Beijing, Beijing, China

The First Affiliated Hospital, Chongqing Medical University

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Chongqing, Chongqing, China

Beijing Daxing District People's Hospital

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Beijing, Beijing, China

Chongqing Hospital of Traditional Chinese Medicine

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Chongqing, Chongqing, China

The Ninth People's Hospital of Chongqing

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Chongqing, Chongqing, China

The Third Affiliated Hospital of Chongqing Medical University

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Chongqing, Chongqing, China

People's Hospital of Liangping District, Chongqing

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Chongqing, Chongqing, China

The People's Hospital of Fengdu County

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Chongqing, Chongqing, China

The People's Hospital of Nanchuan District, Chongqing

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Chongqing, Chongqing, China

Fujian Provincial Hospital

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Fuzhou, Fujian, China

Zhongshan Hospital Affiliated to Xiamen University

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Xiamen, Fujian, China

Shunde Hospital of Southern Medical University, The first People's Hospital of Shunde

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Foshan, Guangdong, China

The Seventh Affiliated Hospital, Sun Yat-sen University

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Shenzhen, Guangdong, China

Zhangzhou People's Hospital

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Zhangzhou, Fujian, China

Panyu Central Hospital

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Guangzhou, Guangdong, China

The People's Hospital of Longhua, The Affiliated Hospital of Southern Medical University

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Shenzhen, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

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Nanning, Guangxi, China

Xiangya Hospital of Central South University

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Changsha, Hunan, China

Anshan Central Hospital, Lishan District

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Anshan, Liaoning, China

Benxi Steel General Hospital of Liaoning Health Industry Group

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Benxi, Liaoning, China

Dalian University Affiliated Xinhua Hospital

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Dalian, Liaoning, China

The First Hospital of China Medical University

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Shenyang, Liaoning, China

Traditional Chinese Hospital of Guyuan

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Guyuan, Ningxia, China

People's Hospital of Longde County

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Guyuan, Ningxia, China

The First People's Hospital of Yinchuan

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Yinchuan, Ningxia, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

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Guangzhou, Guangdong, China

Beijing Tongren Hospital, Capital Medical University

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Beijing, Beijing, China

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